Alcohol Antiseptic Topical Solution

Manufacturer
Healthy Foods & Nutrition Lab de México, S.A. de C.V.
Effective date
2020-05-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:14:44

Label at a glance#

ProductAlcohol Antiseptic Topical Solution
Active ingredientALCOHOL
Label structure10 sections

Dosage and administration

- Place enough product on hands to cover all surfaces. Rub hands together until dry. - Supervise children under 6 years age when using this product to avoid swallowing.

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use(s)

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame. Do not mix use with other household chemicals.

Do not use

OTC - DO NOT USE SECTION

- In children less than two months of age.
- On open skin wounds.

When using this product

OTC - WHEN USING SECTION

keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor

OTC - STOP USE SECTION

if irritation or rash occurs. These maybe signs of serious condititon.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a poision control center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

- Place enough product on hands to cover all surfaces. Rub hands together until dry.
- Supervise children under 6 years age when using this product to avoid swallowing.

Other information

SPL UNCLASSIFIED SECTION

- Store between 15-30C (59-86F)
- Avoid freezing and excesive heat above 40C (104F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Purified water, glicerin, aloe vera extract, tocopheryl acetate (vitamin E).

Questions

OTC - QUESTIONS SECTION

011525553611180 8:00 AM - 5:00 PM (EAST)

Package Labeling: 250ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottle

Package Labeling: 500ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle2Bottle2

Package Labeling: 1L

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle3Bottle3

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77740-001-00Alcohol Antiseptic Topical Solution250 mL in 1 BOTTLEGEL2502
77740-001-01Alcohol Antiseptic Topical Solution500 mL in 1 BOTTLEGEL5002
77740-001-02Alcohol Antiseptic Topical Solution1000 mL in 1 BOTTLEGEL10002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77740-001ALCOHOL ANTISEPTIC TOPICAL SOLUTION (ALCOHOL) GEL [HEALTHY FOODS & NUTRITION LAB DE MÉXICO, S.A. DE C.V.]2Legacy NDC, 3 package rows20200527_a604e558-28f8-321c-e053-2995a90a721b.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77740-00177740-001-00, 77740-001-01, 77740-001-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
a6918d0c-7a91-08bf-e053-2995a90a83a5a604e558-28f8-321c-e053-2995a90a721b2020-05-26WarningsExact identifier
spl id: a6918d0c-7a91-08bf-e053-2995a90a83a5
spl set id: a604e558-28f8-321c-e053-2995a90a721b

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.